Rahul hits back at BJP chief; says Shah, Modi only 2 non-animals in country

New Delhi, Jul 6: The Indian Academy of Sciences, a Bengaluru-based body of scientists, has said the Indian Council for Medical Research's (ICMR) target to launch a coronavirus vaccine by August 15 is "unfeasible" and "unrealistic".

The IASc said while there is an unquestioned urgent need, vaccine development for use in humans requires scientifically executed clinical trials in a phased manner.

While administrative approvals can be expedited, the "scientific processes of experimentation and data collection have a natural time span that cannot be hastened without compromising standards of scientific rigour", the IASc said in a statement.

In its statement, the IASc referred to the ICMR's letter which states that "it is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials".

The ICMR and Bharat Biotech India Limited, a private pharmaceutical company, are jointly developing the vaccine against the novel coronavirus -- SARS-CoV-2.

The IASc welcomes the exciting development of a candidate vaccine and wishes that the vaccine is quickly made available for public use, the statement said.

"However, as a body of scientists including many who are engaged in vaccine development IASc strongly believes that the announced timeline is unfeasible. This timeline has raised unrealistic hope and expectations in the minds of our citizens," it said.

Aiming to launch an indigenous COVID-19 vaccine by August 15, the ICMR had written to select medical institutions and hospitals to fast-track clinical trial approvals for the vaccine candidate, COVAXIN.

Experts have also cautioned against rushing the process for developing a COVID-19 vaccine and stressed that it is not in accordance with the globally accepted norms to fast-track vaccine development for diseases of pandemic potential.

The IASc said trials for a vaccine involve evaluation of safety (Phase 1 trial), efficacy and side effects at different dose levels (Phase 2 trial), and confirmation of safety and efficacy in thousands of healthy people (Phase 3 trial) before its release for public use.

Clinical trials for a candidate vaccine require participation of healthy human volunteers. Therefore, many ethical and regulatory approvals need to be obtained prior to the initiation of the trials, it added.

The IASc said the immune responses usually take several weeks to develop and relevant data should not be collected earlier.

"Moreover, data collected in one phase must be adequately analysed before the next phase can be initiated. If the data of any phase are unacceptable then the clinical trial is required to be immediately aborted," it said.

For example, if the data collected from Phase 1 of the clinical trial show that the vaccine is not adequately safe, then Phase 2 cannot be initiated and the candidate vaccine must be discarded.

For these reasons, the Indian Academy of Sciences believes that the announced timeline is "unreasonable and without precedent", the statement said.

"The Academy strongly believes that any hasty solution that may compromise rigorous scientific processes and standards will likely have long-term adverse impacts of unforeseen magnitude on citizens of India," it said.

New Delhi, Apr 9: Kerala opposition coalition United Democratic Front on Thursday submitted a roadmap to Prime Minister Narendra Modi for staggered lifting of ongoing lockdown due to COVID-19 pandemic.

The coalition led by leader of opposition Ramesh Chennithala has given a set of recommendations to Modi in this regard, which include those made by an expert committee headed by deputy leader of opposition M K Muneer.

The committee was set up to suggest measures to be taken by the government for smooth transition from lockdown to normalcy.

It listed an eight-point exit strategy for removing lockdown in a staggered approach at a district level, with emphasis on hotspots to avoid further spread of virus and ensure smooth restart of economy.

This approach is tuned to the unique needs of each district and all the districts should also be categorised as per their risk levels, the report said.

The report has also been submitted to chief ministers of all states, former prime minister Manmohan Singh, Congress president Sonia Gandhi, senior Congress leader Rahul Gandhi among others.

The committee recommended that COVID-19 rapid testing must be enhanced across the country and the testing target be widened to 500 tests per one lakh population.

"A step-by-step approach is necessary for each sector along with conditions that need to be considered for each sector," the report said.

"There is a need for a comprehensive economic stimulus package in addition to the ones already announced after considering all the industries," it added.

New Delhi, May 30: As the NDA government completes one year of its second term, Prime Minister Narendra Modi listed several achievements and initiatives taken by his government in the past year in an audio message addressed to the people of the country.

PM Modi said, "This day last year began a golden chapter in the history of Indian democracy. It was after several decades that the people of the country voted back a full-term government with a full majority."

"Your role has played a pivotal role in creating this chapter. In such a situation, this day is an opportunity for me to bow to the citizens of the country and the democratic ethos of our nation," said PM Modi.

"Had the situation been normal, I would have got the chance to meet you. Your affection and active support in the past year have given me new energy and inspiration. During this period, the way you have shown the collective powers of democracy, they have become an example for the whole world," he added.

PM Modi talked about several important initiatives taken by his government in 2014 as well as India's demonstration of its mettle through the surgical strike and airstrike.

"Six years ago in 2014, the people of this country voted to bring a major change in the country. You voted to change the country's policy and manner. During that tenure where surgical strike and airstrike took place, one rank one pension, one nation one tax GST, and better MSP for farmers were also fulfilled. That period was dedicated to fulfilling many needs of the country."

He further said that in these years the country has seen systems coming out of the quagmire of inertia and corruption. The country has seen governance change to make life easier for the poor.

"During that period, India's stature in the world increased. By opening bank accounts of poor people, by giving them gas connections, by providing free electricity connections, by building washrooms, by building houses, the dignity of the poor has also been increased," said PM Modi.